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The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women

Primary Purpose

Bone Resorption, Osteoporosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Whey protein supplement
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption focused on measuring Dietary protein, Calcium, Parathyroid hormone, Bone markers, Bone mineral density, IGF-1, Urine Calcium

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Willing to travel to one of the study sites
  • Women age 60 years or greater, men age 70 years or greater
  • Dietary protein intake level between 0.6 g/kg and 1.0 g/kg at baseline

Exclusion Criteria:

  • Active Paget's disease
  • Primary hyperparathyroidism or unexplained hypercalcemia
  • Untreated hyperthyroidism or hyperthyroidism that has resulted from medical treatment
  • Diabetes mellitus type 1
  • Cancer diagnosis for solid malignancies (e.g., cancer of the colon, breast,prostate, lungs, lymphocytes) within the 18 months prior to study entry
  • Long-term use of chemotherapeutic drugs, aromatase inhibitors, or tamoxifen
  • Active treatment for leukemia or multiple myeloma
  • Active inflammatory bowel disease
  • Life expectancy of less than 2 years
  • Current and ongoing use of methotrexate, phenytoin, phenobarbital, or inhaled corticosteroids at a dose of greater than 800 mcg/day
  • Use of raloxifene, estrogen, androgen, progesterone, soy isoflavones, oral glucocorticoids, or herbal supplements with estrogenic activity OR a change in dosage of thyroid medications within the 1 year prior to study entry if unwilling to avoid such agents during the duration of the study
  • Current use of antiresorptive agents (e.g., calcitonin or bisphosphonates). More information about this criterion can be found in the protocol.
  • serum creatinine greater than 1.2 mg/dl
  • History of chronic liver disease or evidence of liver disease at screening
  • Bilateral hip replacement
  • women who have a bone mineral density T-score < -2.5 at either the hip or spine unless they have decided to decline treatment with conventional anti-osteoporotic medications
  • Body mass index (BMI) greater than 32 or less than 19
  • Use of proton-pump inhibitors taken twice daily
  • Fasting glucose level greater than 110 mg/dl
  • Serum albumin level less than 3.0 mg/dl
  • Kidney stones or history of kidney stones within the 3 years prior to study entry

Sites / Locations

  • University of Connecticut Health Center
  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein powder

Placebo carbohydrate

Arm Description

Participants will receive a protein supplement daily (40 g whey protein supplement).

Participants will receive a placebo supplement daily (40 g maltodextrin).

Outcomes

Primary Outcome Measures

Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline
There is no normative data for quantitative computed tomography it is based on local experience.
Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline
There is no normative data for quantitative computed tomography it is based on local experience.
Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months
There is no normative data for quantitative computed tomography it is based on local experience.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2007
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00421408
Brief Title
The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women
Official Title
Impact of a Protein Supplement on Bone Mass in Older Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this study is to determine whether a daily protein supplement will improve bone health among healthy older adults.
Detailed Description
Dietary protein plays an important role in maintaining balanced calcium levels in the body. Protein's impact on skeletal health remains unclear. It is well accepted that increasing dietary protein results in greater excretion of calcium through urine. The excreted calcium is thought to come in part from bone, which would suggest a negative effect on bone health. However, recent studies have found that higher protein intake is, in fact, associated with higher bone mineral density and lower rates of bone loss. The purpose of this study is to determine if a daily protein supplement will improve bone health and hormonal measures of bone metabolism among healthy older men and women who consume low-to-normal levels of dietary protein. This study will last 18 months. For the duration of the study, participants will be randomly assigned to receive either a 40-gram protein supplement or placebo daily. There will be a total of nine study visits that will occur at screening, study entry, Month 1.5, and every three months thereafter. Dietary records, nutritional counseling, glucose finger stick tests, and questionnaires related to falls, physical activity, habits, and study satisfaction will occur at all study visits. Blood and urine collection, functional testing, and bone mineral density (BMD) testing will occur at selected visits. At Months 0 and 18, half of the participants will undergo a quantitative computed tomography (CT) scan to determine bone mineral density.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Osteoporosis
Keywords
Dietary protein, Calcium, Parathyroid hormone, Bone markers, Bone mineral density, IGF-1, Urine Calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein powder
Arm Type
Experimental
Arm Description
Participants will receive a protein supplement daily (40 g whey protein supplement).
Arm Title
Placebo carbohydrate
Arm Type
Placebo Comparator
Arm Description
Participants will receive a placebo supplement daily (40 g maltodextrin).
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein supplement
Intervention Description
40-g whey protein supplement daily for 18 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo supplement daily for 18 months
Primary Outcome Measure Information:
Title
Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline
Description
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Time Frame
Measured at baseline and 18 months
Title
Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline
Description
There is no normative data for quantitative computed tomography it is based on local experience.
Time Frame
Measured at baseline and 18 months
Title
Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline
Description
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Time Frame
Measured at 0 months
Title
Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months
Description
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Time Frame
Measured at 9 months
Title
Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months
Description
There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.
Time Frame
Measured at 18 months
Title
Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline
Description
There is no normative data for quantitative computed tomography it is based on local experience.
Time Frame
Measured at 0 months
Title
Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months
Description
There is no normative data for quantitative computed tomography it is based on local experience.
Time Frame
Measured at 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing to travel to one of the study sites Women age 60 years or greater, men age 70 years or greater Dietary protein intake level between 0.6 g/kg and 1.0 g/kg at baseline Exclusion Criteria: Active Paget's disease Primary hyperparathyroidism or unexplained hypercalcemia Untreated hyperthyroidism or hyperthyroidism that has resulted from medical treatment Diabetes mellitus type 1 Cancer diagnosis for solid malignancies (e.g., cancer of the colon, breast,prostate, lungs, lymphocytes) within the 18 months prior to study entry Long-term use of chemotherapeutic drugs, aromatase inhibitors, or tamoxifen Active treatment for leukemia or multiple myeloma Active inflammatory bowel disease Life expectancy of less than 2 years Current and ongoing use of methotrexate, phenytoin, phenobarbital, or inhaled corticosteroids at a dose of greater than 800 mcg/day Use of raloxifene, estrogen, androgen, progesterone, soy isoflavones, oral glucocorticoids, or herbal supplements with estrogenic activity OR a change in dosage of thyroid medications within the 1 year prior to study entry if unwilling to avoid such agents during the duration of the study Current use of antiresorptive agents (e.g., calcitonin or bisphosphonates). More information about this criterion can be found in the protocol. serum creatinine greater than 1.2 mg/dl History of chronic liver disease or evidence of liver disease at screening Bilateral hip replacement women who have a bone mineral density T-score < -2.5 at either the hip or spine unless they have decided to decline treatment with conventional anti-osteoporotic medications Body mass index (BMI) greater than 32 or less than 19 Use of proton-pump inhibitors taken twice daily Fasting glucose level greater than 110 mg/dl Serum albumin level less than 3.0 mg/dl Kidney stones or history of kidney stones within the 3 years prior to study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl L. Insogna, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16730418
Citation
Newton KM, LaCroix AZ, Levy L, Li SS, Qu P, Potter JD, Lampe JW. Soy protein and bone mineral density in older men and women: a randomized trial. Maturitas. 2006 Oct 20;55(3):270-7. doi: 10.1016/j.maturitas.2006.04.011. Epub 2006 May 26.
Results Reference
background
PubMed Identifier
17048062
Citation
Uenishi K, Ishida H, Toba Y, Aoe S, Itabashi A, Takada Y. Milk basic protein increases bone mineral density and improves bone metabolism in healthy young women. Osteoporos Int. 2007 Mar;18(3):385-90. doi: 10.1007/s00198-006-0228-5. Epub 2006 Oct 18.
Results Reference
background
PubMed Identifier
25844619
Citation
Kerstetter JE, Bihuniak JD, Brindisi J, Sullivan RR, Mangano KM, Larocque S, Kotler BM, Simpson CA, Cusano AM, Gaffney-Stomberg E, Kleppinger A, Reynolds J, Dziura J, Kenny AM, Insogna KL. The Effect of a Whey Protein Supplement on Bone Mass in Older Caucasian Adults. J Clin Endocrinol Metab. 2015 Jun;100(6):2214-22. doi: 10.1210/jc.2014-3792. Epub 2015 Apr 6.
Results Reference
derived

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The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women

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